Organ preservation in distal rectal cancer patients treated with intra-arterial chemotherapy plus total neoadjuvant therapy: a single arm, phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300070620

Enrollment

Unknown

Registered

2023-04-18

Start date

2023-05-01

Completion date

Unknown

Last updated

2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

distal rectal cancer

Interventions

Treatment group:intra-arterial chemotherapy plus total neoadjuvant therapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1)Age between 18 and 70 years. (2)Histologically and immunohistochemically confirmed rectal adenocarcinoma with mismatch repair proficient. (3)Tumor distal edge=4000/ml, neutrophils>=1500/mm3, platelets>=100*109/l, haemoglobin>=10.0g/dL, total bilirubin=60mL/min/body, urine protein/creatinine<1.

Exclusion criteria

Exclusion criteria: (1)Presence of proven distant metastases (including positive lateral pelvic lymph nodes). (2)Patients with a history of a prior malignancy within the past 5 years. (3)Administration contraindication of 5-fluorouracil, raltitrexed, oxaliplatin, and irinotecan. (4)Clinical obstruction requiring an emergency surgery. (5)Uncontrolled active infection. (6)Possibly pregnant, pregnant, or nursing. (7)Recurrent tumor. (8)Prior chemotherapy or radiation therapy to the pelvis. (9)Severe comorbidities (heart failure, uncontrolled diabetes, renal failure, liver failure, hypertension, thrombotic disease, and other similarly serious conditions). (10)Seizure disorders; neurological disease; psychiatric disorders. (11)Patients receiving other anticancer therapy. (12)Other conditions not suitable for this study in the investigator’s judgement.

Design outcomes

Primary

Measure	Time frame
complete response (CR; pathologic CR or sustained cCR>=2 years);	—

Secondary

Measure	Time frame
disease-related treatment failure;overall survival;adverse events;compliance;quality of life;tumour response;organ preservation rate;R0 resection rates;local regrowth rate(Patients underwent W&W observation);salvage surgery rate(patients with local regrowth);surgical complications;pathological response;distant metastasis-free survival;	—

Countries

China

Contacts

Public ContactWenpeng Huang

Affiliated Hospital of Youjiang Medical College for Nationalities

gxnnhwp@126.com+86 15078542317

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026